Description

The ENFit Feeding Tube is an essential medical device designed for the safe and effective delivery of enteral nutrition. Suitable for both nasogastric (NG) and nasoenteric (NI) routes, this tube is equipped with the specialized ENFit® connector, adhering to the international standard ISO 80369-3. This design significantly enhances patient safety by preventing misconnections with non-enteral systems, such as IV lines and catheters.

Key Features

• Connector Design: The ENFit® connector features a unique threaded, twist-to-lock mechanism, ensuring compatibility only with other enteral devices. Its purple color coding allows for easy identification, reducing the risk of errors in medical settings.

• Patient Safety: By minimizing tubing misconnections and medication administration errors, the ENFit Feeding Tube aligns with global safety initiatives. It complies with relevant FDA regulations, contributing to improved patient outcomes across adult and pediatric populations.

Construction and Availability

• Material: Constructed from biocompatible polyurethane (PUR), the tube is available in various sizes to accommodate both pediatric and adult patients. Some models include a hydrophilic coating for smoother insertion.

• Design: Features such as a smooth, rounded distal tip and sideport enhance patient comfort and safety. The device is single-use and sterile, with color-coded hubs for easy size identification.

• Size Options: Common French sizes include 6Fr, 8Fr, 10Fr, and 12Fr, with lengths ranging from 70cm to 140cm. This variety ensures suitability for diverse clinical needs, including gastric and intestinal feeding.

Compatibility and Accessories

• Device Compatibility: The tube is compatible with ENFit syringes, extension sets, and feeding sets. Transition adapters are available to facilitate compatibility with legacy devices during the transition to the ENFit system.

• Intended Use: Designed for both intermittent and continuous feeding, the tube is ideal for use in hospitals, long-term care facilities, rehabilitation centers, and home care environments.

Regulatory Information

• Classification: As a Class II medical device under FDA regulation 21 CFR 876.5980, the ENFit Feeding Tube is intended for prescription use only. It boasts a validated shelf life and is sterilized to a high assurance level, ensuring reliability and safety.

• Biocompatibility: Extensive testing confirms its compliance with ISO and EN standards, providing healthcare professionals with confidence in its performance.

Maintenance Guidelines

• Regular Flushing: To maintain tube patency and prevent clogging, regular flushing with water is recommended. Proper assessment and cleaning of the tube and insertion site help prevent skin complications.

• Single-Use Protocol: Single-use devices should be discarded after use, while reusable accessories require thorough cleaning according to provided instructions.

The ENFit Feeding Tube represents a critical component in the global effort to standardize enteral device connectors, enhancing safety and efficacy in nutritional therapy across healthcare settings.